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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported that the patient had their generator and lead explanted due to an infected collection of fluid around the battery. The patient had been on antibiotics continuously since implant in (b)(6) 2017. Prior to explant, the patient had two neck wound revisions due to would dehiscence. During the second case of wound dehiscence, the patient's electrode coil was "trying to escape. " review of the manufacturer's device history records verified sterilization of the lead and generator prior to release. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

 
Event Description

It was reported by the nurse that they could not identify any reason/s for why there were significant complications with this child and his device for either infections or wound dehiscence. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7723003
Report Number1644487-2018-01293
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/11/2019
Device MODEL Number102
Device LOT Number204122
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/13/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/18/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/26/2018 Patient Sequence Number: 1
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